System Design Quality Engineer
Core
Ensures seamless transition of new products to production by creating validation strategies, managing design control processes, and integrating quality insights into the product lifecycle.
Role type
Quality Engineer (Medical Devices)
Builds
Hardware, software, and system quality plans and validation documentation
Domain
Medical device industry + Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Quality Management, Data Analysis & Interpretation, Design for Quality (DFQ), Root Cause Analysis (RCA), CAPA Methodologies, Regulatory Requirements, Privacy, Safety and Security Risk Assessment, Technical Documentation, Continuous Improvement, Product Quality and Reliability
Preferred skills
Defect Management, Design Verification Planning, Design Validation Planning, Product Test Design
Technologies
Statistical tools
Responsibilities
Create and execute process validation strategies using statistical tools, handle the entire design control process from inputs to verification, draft and update quality engineering documents for hardware/software/systems, integrate quality and reliability insights into the product lifecycle, assess product designs and perform root cause analysis, validate critical design inputs like usability and safety, guide risk management activities, leverage post-market performance data, prepare for quality audits, execute CAPA processes, apply continuous improvement techniques.
Seniority
Mid-level, hands-on IC